Molecules / Tetrabenazine

Tetrabenazine API manufacturers

CAS 58-46-8 ATC N07XX06 Updated 9 July 2026
9
manufacturers with an active filing 9 of them hold a US DMF or a CEP
$3500.00
median export price per kg $2957.03 to $14126.63 · 11 exporters · 2024
17
shortage records on file across 2 countries
96
finished-dose makers across 22 regulators
Showing 9 of 9 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hetero

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for tetrabenazine, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Apotex

Canada
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tetrabenazine, filing since 2013. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Centaur Pharmaceuticals

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tetrabenazine, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Piramal Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tetrabenazine, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Corden Pharma Chenove

France
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tetrabenazine, filing since 2003. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Matrix Pharmacorp

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for tetrabenazine, filing since 2013. Its 2025 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Inke

Spain
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for tetrabenazine, filing since 2022. Its 2023 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Agno Pharma Usa

United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tetrabenazine, filing since 2024.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Rolabo Outsourcing Sl

Spain
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tetrabenazine, filing since 2015.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

6 more manufacturers hold filings for tetrabenazine

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

Piramal PharmaCorden Pharma ChenoveMatrix PharmacorpInkeAgno Pharma UsaRolabo Outsourcing Sl
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Contract manufacturers (3)

Farmhispania Group Spain Inke Spain Omgene Life Sciences India

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (12)

Ajanta Pharma India Dr. Reddy's Laboratories India Pharmascience Canada HIKMA ITALIA Italy Teva Israel Zentiva, k.s Czech Republic Hoffmann-La Roche Switzerland Tuteur S A C I F I A Argentina Aristo Pharma Germany AOP Orphan Pharmaceuticals Austria Axon Drugs Pvt. Ltd, No. 148/12B India Chartwell RX United States

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators
Price band
Customs export unit values for 2024. These are export values rather than contract prices for regulated-market grade material, which are higher.

Who makes tetrabenazine?

Ask Fred which manufacturers are on record for tetrabenazine and what filings they hold.

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Also on this molecule

Price history 2 yrs Shortages 17 Finished dose 12 Contract mfrs 3

Export price by year

Year Median Exporters
2024 $3500.00 11
2022 $4606.03 10

US dollars per kilogram, customs export unit values.